US4568444A - Chemical substance measuring apparatus - Google Patents

Chemical substance measuring apparatus Download PDF

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US4568444A
US4568444A US06/724,641 US72464185A US4568444A US 4568444 A US4568444 A US 4568444A US 72464185 A US72464185 A US 72464185A US 4568444 A US4568444 A US 4568444A
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Prior art keywords
tube
thread member
silver
electrode
wire
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US06/724,641
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Michihiro Nakamura
Makoto Yano
Hidehiko Ikeya
Hiroshi Tsurumi
Osamu Kusudo
Yoshito Hamamoto
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Kuraray Co Ltd
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Kuraray Co Ltd
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Assigned to KURARAY CO., LTD. 1652 SAKAZU, KURASHIKI-CITY, OKAYAMA PREF, JAPAN reassignment KURARAY CO., LTD. 1652 SAKAZU, KURASHIKI-CITY, OKAYAMA PREF, JAPAN ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: HAMAMOTO, YOSHITO, IKEYA, HIDEHIKO, KUSUDO, OSAMU, NAKAMURA, MICHIHIRO, TSURUMI, HIROSHI, YANO, MAKOTO
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/403—Cells and electrode assemblies
    • G01N27/4035—Combination of a single ion-sensing electrode and a single reference electrode

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  • Glass electrodes in particular, are widely used, since they can be adapted to respond selectively to various kinds of chemical substances by changing the composition of the glass membrane or coating a chemically sensitive film on the glass membrane.
  • the miniaturization of a glass electrode for the determination of the local amount of chemical substances in a tissue of a living body involves problems in that reduced strength of the glass membrane results and also in increased resistance of the glass membrane, which naturally leads to a decrease in the response speed.
  • ISFET Ion Sensitive Field Effect Transistor
  • This new-type ion sensor has the following characteristics:
  • the IC technique used permits integration (multiplexing) of various types of ion sensors on one silicon chip.
  • the ISFET as a sensor for monitoring the quantity of chemical substances in a living body by inserting it into the tissue of the body, is attracting wide attention. Further, it is known that the ISFET can be adapted to respond to various kinds of substances by modifying its ion-sensitive membrane.
  • the reference electrode In order to measure the quantity of chemical substances contained in the solution being assayed by using said ISFET or the conventional glass electrode as a potentiometric electrode for chemical-substance measurement, there must be a reference electrode having a constant potential in its interface with the being-assayed solution regardless of the composition of the solution. Therefore, the reference electrode is of such construction that the to-be-assayed solution may be brought into contact with an internal solution housed in a closed tube and having a constant composition, through a small space called liquid junction which is provided at front end of the tube. In the internal solution within the tube there is immersed an internal electrode such as Ag-AgCl electrode.
  • a reference electrode used together with ion sensors, such as ISFET, particularly for the purpose of living-body monitoring must be miniaturized enough to be insertible in a living body and must be steam-autoclavable.
  • ion sensors such as ISFET
  • the smaller the reference electrode in size the less is the quantity of the internal solution housed in the tube. In a prolonged measurement operation, therefore, it is very important to prevent the outflow of the internal solution.
  • Such reference electrode having such sol or hydrogel contained therein as the internal solution involves maintenance difficulties, though it is effective to some extent for the prevention of outflow of the internal solution in the course of measurement and also for the prevention of bubble generation in the internal solution during storage.
  • sols of organic polymers such as, for example, agar-agar, gelatine, polyvinyl alcohol, and polyhydroxy methacrylate, when heated, produce a potassium permanganate reducing substance which may be hazardous to living bodies.
  • Polyhydroxyethyl methacrylate sol cannot be used as the internal solution because it is liable to separate into a polymer phase and a water phase upon heating.
  • Hyperfine silica hydrogel is so high in viscosity that it is difficult, if not impossible, to put the gel into the tube.
  • Said reference electrode comprises: a one piece tube, an internal solution housed in this tube and gelled by 2 ⁇ 10% by weight of polyvinyl alcohol and 0.1 ⁇ 2% by weight of a crosslinking agent selected from the group consisting of titanium compounds, zirconium compounds, and vanadium compounds, an internal electrode immersed in the internal solution, and a liquid junction provided in the front end portion of the tube and with communicating between the inside of the tube and the outside thereof.
  • a crosslinking agent selected from the group consisting of titanium compounds, zirconium compounds, and vanadium compounds
  • the chemical-substance measuring apparatus for measuring the quantities of chemical substances contained in a solution to be assayed in accordance with the invention comprises:
  • a chemical-substance sensitive sensor consisting of a potentiometric electrode capable of responding selectively to specific chemical substances
  • a liquid-junction type reference electrode including a tube, a porous thread member housed in the front end opening of the tube and having a pore capacity of 0.2 cc/g or more and at least the surface of which is hydrophilic, a silver-silver chloride wire housed in the tube so that at least at its one end the wire is in contact with the thread member and which extends along the tube and is connected to a connector at the other end opening of the tube, an electrical insulating resin filled in said tube at least at the front end portion thereof for fixing both the silver-silver chloride wire and the thread member by contact therewith and for stopping said tube, and an internal solution retained by suction in said porous thread member.
  • FIG. 1 is a circuit diagram showing an electric circuit for measuring the quantities of chemical substances in a to-be-assayed solution by means of a chemical-substance measuring apparatus including a chemical-substance sensitive sensor using an ISFET as a potentiometric electrode, and a liquid-junction type reference electrode.
  • a chemical-substance measuring apparatus including a chemical-substance sensitive sensor using an ISFET as a potentiometric electrode, and a liquid-junction type reference electrode.
  • FIGS. 2 and 3 are sectional views showing a liquid-junction type reference electrode used in the chemical-substance measuring apparatus according to the invention.
  • FIGS. 4 and 5 are sections showing another form of the chemical-substance measuring apparatus, in which the chemical-substance sensitive sensor and the liquid-junction reference electrode are housed in one tube.
  • FIG. 6 is a graph showing a performance comparison between the liquid-junction type reference electrode employed in the chemical-substance measuring apparatus of the invention and the conventional liquid-junction type reference electrode.
  • FIGS. 2 and 3 are sections showing a liquid-junction reference electrode employed in a chemical-substance measuring apparatus according to the invention.
  • the reference electrode 10 is used in conjunction with aforesaid potentiometric electrode.
  • the reference electrode comprises a tube 15, a porous thread member 11 housed in the front end opening of the tube and having hydrophilic properties at least with respect to its surface, a silver-silver chloride wire 12 housed in the tube so that at least at its one end the wire is in contact with said thread member and which extends along the tube and is connected to a connector 13 at the other end opening of the tube, an electrical insulating resin filled in said tube at least at the front end portion thereof for fixing both the silver-silver chloride wire and the thread member by contact therewith and for stopping said tube, and an internal solution retained by suction in said porous thread member.
  • the tube 15 is formed of a waterproof material.
  • polyamides such as Nylon 6, Nylon 11, and Nylon 12, polyesters, polypropylenes, polyvinyl chlorides, and rubbery resins, such as silicone rubbers, urethane rubbers, and polyisoprene rubbers are used.
  • thread materials composed of hydrophilic polymers, e.g., polyvinyl alcohol, ethylene-vinyl alcohol copolymer, hydroxyethyl methacrylate; reaction products of these polymers through reaction with glutaraldehyde, formaldehyde, or the like; and polyacetyl cellulose, and polyacrylonitrile.
  • hydrophilic polymers e.g., polyvinyl alcohol, ethylene-vinyl alcohol copolymer, hydroxyethyl methacrylate
  • reaction products of these polymers through reaction with glutaraldehyde, formaldehyde, or the like
  • polyacetyl cellulose and polyacrylonitrile
  • porous thread materials composed of hydrophobic polymers, such as polypropylene, polytetrafluoroethylene, polyethylene, polystyrene, and polysulfone, and which are hydrophilically surface treated, may be used for the purpose.
  • hydrophilic treatment techniques available are sulfonation and the like chemical treatment; and also treatment with ethanol, surface active agent, or the like.
  • Hydrophilication of a porous thread member made of a hydrophobic polymer should be effected to such extent as to allow water to be spontaneously sucked into the pores of the tread member by capillarity.
  • the porous thread member must have a porosity such that its pore capacity is 0.2 cc/g or more to assure that the internal solution is retained in the pores by suction.
  • a pore capacity of less than 0.2 cc/g is undesirable, because it is insufficient to retain the internal solution, which means that the internal resistance of the reference electrode is too large.
  • pore capacity referred to herein means a value resulting from the division of the total pore capacity (cc) as measured by a mercury penetration porosimeter, by the weight of the sample (g).
  • the thread member may be a monofilament, multifilament, or staple fiber, in single form as such or in bundle form or in twine form, or it may be in hollow-fiber form.
  • the thread member has pores of 0.01 ⁇ 10 ⁇ each in mean diameter substantially evenly distributed over its cross section. The diametral size of such pore within the range of 0.01 ⁇ 10 ⁇ may vary stepwise or continuously in the inward direction from the fiber surface or in the reverse direction.
  • the thread member may additionally have a very thin skin layer on its surface.
  • the pore diameter is more than 10 ⁇ , the mechanical strength of the porous thread member is lower and the diffusion of chlorine ions in the internal solution is faster; and accordingly, the potential of the reference electrode is likely to drift when there occurs a change in the chlorine ion concentration in the solution to be assayed. Conversely, if the pore diameter is less than 0.01 ⁇ , the diffusion of ions in the internal solution is excessively slow and the internal resistance of the reference electrode is greater, which results in greater induced noise.
  • the outer diameter of the thread member should be as small as possible.
  • a hollow fiber one having an outer diameter of 50 ⁇ 3000 ⁇ and a membrane thickness of 10 ⁇ 500 ⁇ is normally used.
  • the porous thread member mentioned above may be produced by a conventional spinning technique.
  • a polyvinyl alcohol-based porous hollow fiber may be produced by the process disclosed in Japanese Published Unexamined Patent Application No. 21420/1977.
  • a porous polysulfone hollow fiber may be produced by the process disclosed in Japanese Published Unexamined Patent Application No. 91822/1983.
  • the thread member mentioned above is housed in the front end opening of the tube.
  • the thread member should be placed in the tube so that its front end is substantially level with the front end of the tube. If the thread member inserted in the tube is too short, the internal solution retained by suction in the thread member may diffuse and flow out into the solution to be assayed. Therefore, the thread member must have such a length that such diffusion and outflow of the internal solution can be reasonably prevented. Such length can be suitably determined according to the configuration of the thread member. In the case of the reference electrode shown in FIG. 2, if the thread member used therein is of a 0.3 mm diameter, for example, the length of the thread member inserted in the tube should usually be more than 1.5 cm.
  • a porous monofilament 16 or the like is inserted in the front end opening of the hollow fiber or throughout the length of hollow portion of the fiber in order to close the hollow portion.
  • a hollow fiber having an inner diameter of 50 ⁇ or less is used, if the front end of the silver-silver chloride wire is spaced apart by more than 2 cm from the liquid junction, any abrupt change in the chlorine ion concentration of the internal solution, that is, any abrupt change in the potential of the silver-silver chloride electrode can be prevented without the necessity of the hollow portion being closed up.
  • the silver-silver chloride wire housed in the tube must be in contact at its front end with the thread member.
  • the silver-silver chloride wire is in contact at its front end with the surface of the thread member.
  • the front end of the silver-silver chloride wire is inserted in the hollow portion of the hollow fiber so that its front end is in contact with the inner surface of the hollow fiber.
  • the silver-silver chloride wire extends along the tube and is connected at the other end opening of the tube to the connector.
  • a lead wire may be connected to one end of the silver-silver chloride wire, the other end of which is in contact with the thread member, so that the lead wire extends along the tube and is connected at the other end opening of the tube to the connector.
  • the internal solution retained by suction in the thread member is usually a saturated KCl solution, if ordinary pH measurement is intended.
  • the internal solution is of a composition suitable for the purpose.
  • the internal solution must meet the following conditions:
  • the liquid junction potential difference becomes smaller the closer the mobilities of positive and negative ions moving in the liquid junction at which the solution to be assayed and the thread member are in contact with each other.
  • the positive and negative ions in the internal solution should be of equal mobility, and that their concentration in the internal solution should be greater than that in the solution to be assayed.
  • electrolytes in which the positive and negative ions are equal in mobility are KCl and NH 4 Cl.
  • the salt concentration of the blood is close to 0.15M NaCl and accordingly there will occur no inter-solution potential difference.
  • the aforesaid reference electrode before it is put in use, is immersed, at its front end portion, in the internal solution so that the internal solution is retained by suction in the thread member. Only after that it is put in use. In this case, suction of the internal solution into the thread member is accomplished by natural suction that exists through the capillarity of micro-pores of the thread member.
  • the above described reference electrode can be miniaturized. For example, by using a porous thread member having an outer diameter of 0.2 mm and a length of 2 cm, a silver-silver chloride wire having a diameter of 0.1 mm, and a tube of silicone rubber having an inner diameter of 0.3 mm and an outer diameter of 0.4 mm, which is insertible into a living body, it is possible to obtain a very slender reference electrode.
  • the internal solution (an electrolyte solution containing chlorine ions) is retained in the micro-pores of the porous thread member, and the porous thread member is held in close contact with the silver-silver chloride electrode and extends up to the liquid junction port; therefore, although it is of a miniature size, there is no possible breakage of electric conductivity between the silver-silver chloride electrode and the solution to be assayed. Even if there should occur any inclusion of bubbles in the space formed at the joint between the silver-silver chloride wire and the thread member (e.g., at 17 in FIG.
  • the above described reference electrode uses a prefabricated porous thread member as a holder for the internal solution, and therefore it is very simple to manufacture.
  • cross-linking reaction takes place only after a solution containing the polymer and a crosslinking agent is poured into the reference electrode.
  • the known reference electrode therefore, proper control of crosslinking reaction is difficult and its assembly is very complicated.
  • the use of a porous filament or yarn provides several distinct advantages. Since such filament or yarn is produced by spinning techniques on a mass production basis and therefore quantities of such filament or yarn, having uniform performance quality are readily available.
  • the liquid junction potential difference involved is very small as compared with the case where a polymer gel is used. Accordingly, it has also been found that the use of such thread member can minimize measurement errors with the reference electrode.
  • a hydrophilic polymer sol or gel in particular, is used as an internal solution holder, there develops an abnormal potential of more than 5 mV in a solution containing borate (e.g., a buffer solution of 9.18 pH), whereas in the case of a porous thread member being used as an internal solution holder, such abnormal potential is reduced to less than 3 mV.
  • FIG. 4 illustrates a chemical substance measuring apparatus incorporating a multiple electrode comprising an ISFET and a liquid-junction type reference electrode both housed in one tube.
  • the gate portion of an ISFET 20 projects outwardly from the front end of a first tube 21, and the electrode portion of the ISFET is fixedly buried in a waterproof electrical insulating resin 22 which stops the front end opening of the first tube.
  • a lead wire 23, connected to the electrode portion of the ISFET, extends along the tube and is connected to a connector 24 at an opening of the tube at the other end thereof.
  • the first tube 21 to which the ISFET 20 is fixed is inserted in a second tube 25.
  • a porous hollow fiber 26 is housed in the front end portion of a cavity defined by the two tubes.
  • a silver-silver chloride wire 27 which is in contact at its one end with the hollow fiber 26 and which is connected at the other end thereof to the connector 24 at the opening at the other end of the tubes.
  • This electrical insulating resin may be filled in the entire interior space of the first tube and also in the entire cavity defined by the first and second tubes. If an ISFET having a plurality of sensor gates is employed, it is possible to provide an apparatus capable of measuring a plurality of chemical substances.
  • FIG. 5 illustrates an embodiment comprising a tubular body having at least two independent cavities (e.g., a double lumen catheter 30).
  • the gate portion of an ISFET 31 projects from the catheter at the front end of one cavity thereof and the electrode portion of the ISFET is fixedly buried in a waterproof electrical insulating resin 32 which stops the front end opening of the cavity.
  • a lead wire 33 connected to the electrode portion of the ISFET, extends along the cavity and is connected to a connector 34 at the other end opening of the catheter.
  • a porous hollow fiber 35 is housed in another cavity of the catheter at the front end portion thereof. In the hollow space of the hollow fiber there is inserted one end portion of a silver-silver chloride wire 36.
  • the silver-silver chloride wire extends along the cavity and is connected to the connector 34 at the other end of the catheter.
  • a porous hollow fiber is used and there is provided a sufficient length (L) between the front opening of the hollow fiber and the front end of the silver-silver chloride inserted in the hollow space of the hollow fiber; and therefore, the front opening of the hollow fiber is not closed.
  • masses of electrical insulating resin 37 are filled in the cavities of the catheter. If a tubular body having three or more independent cavities is employed and a plurality of ISFET's capable of responding selectively to different chemical substances are each housed in one of the cavities, it is possible to provide an apparatus capable of measuring a plurality of chemical substances.
  • a guard electrode 38 is shown which connects the solution to be assayed and a source follower circuit to eliminate alternate-current induced interference and which thereby permit a more accurate measurement.
  • ISFET is used as a potentiometric electrode
  • alternate-current induced interferences such as entry into the sensor circuit through a grounding conductor of alternate current from an indoor AC connection or leaking along the floor, may cause fluctuations in the source potential and thus make it difficult to perform accurate measurement of ion concentrations.
  • a miniaturized liquid-junction type reference electrode embodies the use of high impedance (e.g. 100 K ⁇ or more is used) and where the drain current is 30 ⁇ A or below, this alternating current induced interference may be considerable, causing a great effect upon the measurement.
  • This guard electrode is connected to an isolation circuit, external signals, chiefly of an alternate current flowing in living bodies, will not flow in the sensor circuit, thereby permitting a constantly accurate measurement.
  • This guard electrode is made of a conductive metal such as platinum or silver.
  • This guard electrode, together with the ISFET, is housed in the cavity.
  • a guard wire, connected to the guard electrode, extends along the cavity and is connected to the connector at the other end of the catheter.
  • a porous thread member having a pore capacity of more than 0.2 cc/g and at having it least the surface of which being hydrophilic is used as a holder for the internal solution of the liquid-junction type reference electrode incorporated in the chemical substance measuring apparatus according to the present invention.
  • the liquid-junction type reference electrode in accordance with this invention is free from the possibility of discontinuity between the internal solution and the external solution to be assayed with the assurance of improved stability and accuracy.
  • the reference electrode is easy to assemble and is of a miniaturized type. Therefore, the reference electrode, employed in conjunction with a potentiometric electrode, serves as a very practical chemical substance measuring apparatus for measuring the quantities of chemical substances in a living body.
  • the hollow fiber so treated was washed in water.
  • the polyvinyl alcohol hollow fiber had an outer diameter of 0.5 mm and an inner diameter of 0.3 mm.
  • An electronographic examination of a section of the hollow fiber showed that there were pores of 0.02 ⁇ 2 ⁇ dia evenly distributed throughout the cross section.
  • the pore capacity of the fiber as determined by a mercury porosimeter was 0.23 cc/g.
  • the silver-silver chloride wire, the hollow fiber, and the silicone rubber tube were fixed. Then, the front end portion of the silicon rubber tube was immersed in a physiological salt water to allow the physiological salt water to be sucked into the hollow fiber by capillarity.
  • a porous polyvinyl alcohol hollow fiber was produced in same manner as in Example 1, except that 2 kg of ethylene glycol was used in the spinning solution instead of 4 kg of same.
  • the hollow fiber obtained had a pore capacity of 0.17 cc/g.
  • the outer and inner diameters of the hollow fiber were identical with those in Example 1.
  • a reference electrode similar to the one fabricated in Example 1. Inter-solution potential difference measurements made with this electrode showed results similar to those in Example 1. However, this reference electrode gave a noise level of about ⁇ 1 mV.
  • a silver-silver chloride wire having a diameter of 0.25 mm was fixed with silicone RTV in a silicone rubber tube having an inner diameter of 0.5 mm and an outer diameter of 1.0 mm.
  • An aqueous solution containing 5 wt % of polyvinyl alcohol (with a polymerization degree of 1700), 0.5 wt % of titanium lactate as a crosslinking agent, and 0.9 wt % (0.154M) of sodium chloride was injected by a syringe through the end opening of the silicone rubber tube. Then, the composite was allowed to stand overnight in physiological salt water for completion of crosslinking reaction.
  • the potential of the reference electrode relative to that of the standard electrode K8040 was measured in same manner as in Example 1.

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US06/724,641 1984-04-30 1985-04-18 Chemical substance measuring apparatus Expired - Lifetime US4568444A (en)

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JP59088185A JPS60231156A (ja) 1984-04-30 1984-04-30 液絡式の比較電極
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US12150250B2 (en) 2017-10-24 2024-11-19 Dexcom, Inc. Pre-connected analyte sensors
US11382540B2 (en) 2017-10-24 2022-07-12 Dexcom, Inc. Pre-connected analyte sensors
US11350862B2 (en) 2017-10-24 2022-06-07 Dexcom, Inc. Pre-connected analyte sensors
US11331022B2 (en) 2017-10-24 2022-05-17 Dexcom, Inc. Pre-connected analyte sensors

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JPH0374951B2 (enrdf_load_stackoverflow) 1991-11-28
EP0160566A2 (en) 1985-11-06
EP0160566B1 (en) 1990-07-04
EP0160566A3 (en) 1987-05-27
JPS60231156A (ja) 1985-11-16
DE3578518D1 (de) 1990-08-09

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